Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effec
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are: Does increased activity lead
| Condition(s) | Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are: Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels? Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be |
| Who can participate | Inclusion Criteria: * Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid) * Distal Third (\<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement) * Insolated Radial Shaft Fracture (diaphyseal) * Radial and Ulna Shaft Fracture (diaphyseal) Exclusion Criteria: * Initial presentation \>7 days from the time of injury * Pathologic fracture * Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias) * Any patient with known bone fragility condition (ex. Osteogenesis imperfecta) * If operative treatment is required at initial presentation |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Lead sponsor | Vanderbilt University Medical Center |
| Locations | Nashville, Tennessee, United States |
| Start date | 2025-01-16 |
| NCT ID | NCT06799377 |
| Official listing | https://clinicaltrials.gov/study/NCT06799377 |